ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Launched by ABBOTT MEDICAL DEVICES · Jul 5, 2023
Trial Information
Current as of July 24, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
ENVISION is a prospective, multi-center clinical investigation at up to 115 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in two separate cohorts: (1) a pivotal randomized cohort and (2) a valve-in-valve (ViV) cohort.
The objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for...
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- 1. Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:
- • 1. Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and \< 8% at 30 days
- • 2. Low risk: estimated risk of overall surgical mortality \< 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator
- • 2. New York Heart Association (NYHA) Functional Classification of II, III, or IV
- • 3. Degenerative aortic valve stenosis
- Key Exclusion Criteria:
- • 1. In the opinion of the Investigator, life expectancy is less than 2 years
- • 2. Evidence of an acute myocardial infarction \[defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation\] within 30 days prior to index procedure
- • 3. Untreated clinically significant coronary artery disease requiring revascularization
- • 4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure
- • 5. Blood dyscrasias as defined: leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \< 50,000 cells/mm³); history of bleeding diathesis or coagulopathy
- • 6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
- • 7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
- • 8. Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
- • 9. Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.)
- • 10. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
- • 11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)
- • 12. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.
- • 13. Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram
- • 14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
- • 15. Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)
- • 16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
- • 17. Minimum access vessel diameter of \< 5.0 mm for small FlexNav Delivery System and \< 5.5 mm for large FlexNav Delivery System
- • 18. Eccentricity ratio of the annulus \< 0.73
- • Additional Exclusion Criteria for Pivotal Randomized Cohort
- • 1. Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk
- • 2. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
- • 3. Mixed aortic valve disease
- • 4. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
- • 5. Inadequate aortic valve calcification
- • 6. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
- • Additional Exclusion Criteria for ViV Cohort
- • 1. Failing valve has moderate or greater paravalvular regurgitation.
- • 2. Known severe prosthesis-patient mismatch
- • 3. Failing valve is unstable, rocking, or not structurally intact.
- • 4. Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic.
- • 5. Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve.
- • 6. Increased risk of coronary obstruction by prosthetic leaflets of the index valve
About Abbott Medical Devices
Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Cincinnati, Ohio, United States
Toronto, Ontario, Canada
Portland, Oregon, United States
Gainesville, Georgia, United States
Thousand Oaks, California, United States
Norfolk, Virginia, United States
Stanford, California, United States
Washington, District Of Columbia, United States
Memphis, Tennessee, United States
New York, New York, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Chicago, Illinois, United States
Miami, Florida, United States
Dallas, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Kansas City, Missouri, United States
Buffalo, New York, United States
Kalamazoo, Michigan, United States
Charlottesville, Virginia, United States
Cleveland, Ohio, United States
Tallahassee, Florida, United States
Pittsburgh, Pennsylvania, United States
Mineola, New York, United States
Little Rock, Arkansas, United States
Midland, Michigan, United States
Phoenix, Arizona, United States
New Orleans, Louisiana, United States
Atlanta, Georgia, United States
Wausau, Wisconsin, United States
Tulsa, Oklahoma, United States
Evanston, Illinois, United States
Manchester, New Hampshire, United States
Indianapolis, Indiana, United States
Albany, New York, United States
Largo, Florida, United States
Plano, Texas, United States
Wynnewood, Pennsylvania, United States
La Jolla, California, United States
Greenville, North Carolina, United States
Milwaukee, Wisconsin, United States
Asheville, North Carolina, United States
Vancouver, British Columbia, Canada
Morristown, New Jersey, United States
Wichita, Kansas, United States
Calgary, , Canada
Sioux Falls, South Dakota, United States
Fontana, California, United States
New York, New York, United States
Montréal, Quebec, Canada
Orlando, Florida, United States
New York, New York, United States
Saint George, Utah, United States
Wichita, Kansas, United States
Austin, Texas, United States
Mechanicsburg, Pennsylvania, United States
Evanston, Illinois, United States
La Jolla, California, United States
Honolulu, Hawaii, United States
Oak Lawn, Illinois, United States
New York, New York, United States
Columbus, Ohio, United States
Montréal, Quebec, Canada
Saint John, , Canada
Denver, Colorado, United States
Evanston, Illinois, United States
Saint George, Utah, United States
Patients applied
Trial Officials
Barathi Sethuraman
Study Director
Abbott Structural Heart
Michael Reardon, MD
Study Chair
The Methodist Hospital Research Institute
Azeem Azeem, MD
Study Chair
Montefiore Medical Center
Bassem Chehab, MD
Principal Investigator
Ascension Via Christi Hospitals Wichita, Inc.
Ibrahim Sultan, MD
Principal Investigator
The University of Pittsburgh Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported